Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Improving Varenicline Adherence and Outcomes in Homeless Smokers

This study has been completed.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute Identifier:
First received: November 5, 2008
Last updated: September 2, 2014
Last verified: September 2014
the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.

Condition Intervention Phase
Tobacco Use Cessation
Other: Varenicline plus Motivational Interviewing counseling
Other: Varenicline without counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Varenicline Adherence and Outcomes in Homeless Smokers

Resource links provided by NLM:

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 7-day point prevalence abstinence from smoking [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence to treatment [ Time Frame: 12 weeks and 6 months after enrollment ] [ Designated as safety issue: No ]
  • Moderating effects of psychiatric co-morbidities and other substance abuse on treatment [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]

Enrollment: 428
Study Start Date: September 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive NRT and Motivational Interviewing counseling
Other: Varenicline plus Motivational Interviewing counseling
Motivational Interviewing; 8 weeks of counseling
Other Name: Chantix
Active Comparator: 2
Varenicline plus brief advice
Other: Varenicline without counseling
Brief advice, one time during initial session
Other Name: Chantix

Detailed Description:

Despite significant declines in cigarette smoking rates among adults in the United States in the last few decades, smoking rates remain high among poor and underserved populations. One underserved group is the 4 million homeless persons in the US among whom cigarette smoking rate is an alarming 70% or more; these rates are 3 times higher than national average. Two of the three leading causes of death among homeless persons, heart disease and cancer are tobacco related.2, 3 Despite very high smoking prevalence and disease burden in this population smoking cessation research have not been extended to the homeless. Recent studies including data from our research team show a considerable degree of readiness to quit smoking by homeless smokers and that nicotine replacement therapy (NRT) plus counseling show promise. However, homeless persons face many challenges that may constitute barriers for them to adhere to smoking cessation treatments even if such treatments have been proven effective in the general population. In order to reduce smoking-related health disparities within this underserved population, it is critical that cessation interventions including strategies to improve treatment adherence be developed to include homeless smokers. The primary aim of this study is to assess the effects of adherence-focused motivational interviewing (MI) to help homeless persons quit smoking.

Recruitment and retention will be enhanced by use of bus passes for transportation, debit cards, attractive intervention materials, collaboration with homeless shelters, and advice from a community advisory board. If successful, this study will provide a model for how to overcome barriers to cancer prevention services among homeless persons. It will also provide the impetus for policy changes directed at increasing homeless persons' access to smoking cessation pharmacotherapy and treatment.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • currently homeless
  • smoke 5 or more cigarettes per day
  • smoked 100 cigarettes in lifetime
  • aged 18 years or older

Exclusion Criteria:

  • unstable mental illness
  • pregnancy
  • current history of psychoactive or alcohol dependence or psychotic disorder
  • cognitive impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00786149

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Kolawole S Okuyemi, MD,MPH University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT00786149     History of Changes
Other Study ID Numbers: 0708M14444  HL081522  NIH-522 
Study First Received: November 5, 2008
Last Updated: September 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Underserved populations
Nicotine replacement therapy
Cancer Prevention and control

Additional relevant MeSH terms:
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on October 21, 2016